This position plays a key technical role in leading and supporting the effective execution of the sites’ Quality Management System (QMS), with a primary focus on the governance and execution of the Change Control process
Job Summary
This position plays a key technical role in leading and supporting the effective execution of the sites’ Quality Management System (QMS), with a primary focus on the governance and execution of the Change Control process.
The role requires strong technical expertise to assess, advise on, and support changes impacting validated systems, manufacturing processes, equipment, software, and quality documentation, ensuring appropriate risk assessment, validation strategy, and regulatory compliance.
The individual will partner closely with Engineering, Manufacturing, IT, Validation, and Regulatory stakeholders, and liaise with Franchise, Sector, and Enterprise teams to drive harmonization, standardization, and simplification across Change Control and other key QMS processes and systems.
Matching Summary
This position plays a key technical role in leading and supporting the effective execution of the sites’ Quality Management System (QMS), with a primary focus on the governance and execution of the Change Control process.
Skills & Requirements
Must-have
Change Control process governance
Quality Management System (QMS)
validated systems and manufacturing processes
regulatory compliance (GMP, GxP)
risk assessment and validation strategy
technical quality system subject matter expert
Nice-to-have
harmonization, standardization, and simplification
data driven decision making
inclusive work environment
diversity and dignity of employees
Key Requirements
Bachelors or equivalent University degree
six (6) years of professional experience
experience in a Quality related medical device or pharmaceutical manufacturing environment
Technical experience in change control and validation systems/processes
Proficiency (verbal and written) in the English language